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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00887198
Registration number
NCT00887198
Ethics application status
Date submitted
18/04/2009
Date registered
23/04/2009
Date last updated
25/06/2018
Titles & IDs
Public title
Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
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Scientific title
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
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Secondary ID [1]
0
0
COU-AA-302
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Secondary ID [2]
0
0
CR016927
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
0
0
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Condition category
Condition code
Cancer
0
0
0
0
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Abiraterone acetate
Treatment: Drugs - Placebo
Treatment: Drugs - Prednisone
Placebo comparator: Placebo + prednisone - Placebo plus prednisone
Experimental: Abiraterone + prednisone - Abiraterone acetate plus prednisone
Treatment: Drugs: Abiraterone acetate
1000 mg per day (4 x 250-mg tablets) taken orally.
Treatment: Drugs: Placebo
4 placebo tablets per day taken orally.
Treatment: Drugs: Prednisone
5 mg tablet orally twice daily.
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival
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Assessment method [1]
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Overall survival is defined as the time from randomization to date of death from any cause.
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Timepoint [1]
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0
From randomization (Day 1) up to end of study (Month 60)
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Primary outcome [2]
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Radiographic Progression-free Survival (rPFS)
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Assessment method [2]
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0
The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (\>=) 2 new lesions compared to baseline was observed in less than (\<) 12 weeks from randomization and was confirmed by a second bone scan taken \>=6 weeks later showing \>=2 additional new lesions (a total of \>=4 new lesions compared to baseline), b) the first bone scan with \>=2 new lesions compared to baseline was observed in \>=12 weeks from randomization and the new lesions were verified on the next bone scan \>=6 weeks later (a total of \>=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI); 3) death from any cause.
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Timepoint [2]
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0
From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)
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Secondary outcome [1]
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0
Time to Opiate Use for Prostate Cancer Pain
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Assessment method [1]
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0
The time interval from the date of randomization to the date of opiate use for cancer pain. Participants who have no opiate use at the time of analysis were censored at the last known date of no opiate use for cancer pain. Participants with no assessment were censored at the date of randomization.
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Timepoint [1]
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0
From randomization (Day 1) up to first opiate use or end of study (Month 60)
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Secondary outcome [2]
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Time to Initiation of Cytotoxic Chemotherapy
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Assessment method [2]
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The time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer. Participants who had no cytotoxic chemotherapy administration at the time of analysis were censored at the last known date when no cytotoxic chemotherapy was administered. Participants with no assessment were censored at the date of randomization.
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Timepoint [2]
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0
From randomization (Day 1) up to initiation of cytotoxic chemotherapy or cutoff date (Month 18)
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Secondary outcome [3]
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Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point
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Assessment method [3]
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The time interval from the date of randomization to the first date at which there was at least a 1 grade change (worsening) in the ECOG performance status grade. Participants who had no deterioration in ECOG performance status grade at the time of the analysis were censored at the last known date of no deterioration. ECOG is a 5-point scale, where 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead. Participants with no assessment were censored at the date of randomization.
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Timepoint [3]
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0
From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)
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Secondary outcome [4]
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0
Time to Prostate-specific Antigen (PSA) Progression
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Assessment method [4]
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The time interval from the date of randomization to the date of PSA progression as defined in the protocol-specific prostate cancer Working Group 2 (PCWG2) criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanogram/milliliter ((ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks. Participants who had no PSA progression at the time of the analysis were censored at the last known date of no PSA progression. Participants with no on-study PSA assessment or no baseline PSA assessment were censored at the date of randomization.
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Timepoint [4]
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0
From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18)
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Secondary outcome [5]
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Number of Participants With Treatment Emergent Adverse Events
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Assessment method [5]
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An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.
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Timepoint [5]
0
0
From first dose of study drug up to 30 days after the last dose of study drug
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Secondary outcome [6]
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0
Mean Plasma Concentrations of Abiraterone
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Assessment method [6]
0
0
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Timepoint [6]
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0
Up to Cycle 5, Day 1
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Secondary outcome [7]
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0
Maximum Plasma Concentrations of Abiraterone
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Assessment method [7]
0
0
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Timepoint [7]
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0
Up to Cycle 5, Day 1
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Secondary outcome [8]
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0
Area Under the Plasma Concentration-time Curve From Time 0 to Time the Last Quantifiable Concentration of Abiraterone (AUC[0-infinity])
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Assessment method [8]
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0
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
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Timepoint [8]
0
0
Up to Cycle 5, Day 1
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Secondary outcome [9]
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Elimination Half-Life (t1/2)
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Assessment method [9]
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The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
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Timepoint [9]
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0
Up to Cycle 5, Day 1
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Eligibility
Key inclusion criteria
* Metastatic castration-resistant prostate cancer (CRPC)
* Previous anti-androgen therapy and progression after withdrawal
* ECOG performance status of either 0 or 1
* Medical or surgical castration with testosterone less than 50 ng/dL
* Life expectancy of at least 6 months
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Prior cytotoxic chemotherapy or biologic therapy for CRPC
* Prior ketoconazole for prostate cancer
* Known brain metastasis or visceral organ metastasis
* Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/04/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
25/05/2017
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Sample size
Target
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Accrual to date
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Final
1088
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Adelaide
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- Camperdown
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- Footscray
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- Frankston
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- Garran
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Recruitment hospital [6]
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- Geelong
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Recruitment hospital [7]
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- Heidelberg
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Recruitment hospital [8]
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- Herston
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- Hornsby
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Recruitment hospital [10]
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- Kogarah
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Recruitment hospital [11]
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- Kurralta Park
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- Lismore
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- Liverpool
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- Malvern
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- Parkville
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- Perth
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- South Brisbane
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- Southport
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- Subiaco
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment postcode(s) [2]
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- Camperdown
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Recruitment postcode(s) [3]
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- Footscray
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- Frankston
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- Garran
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- Geelong
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- Heidelberg
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Recruitment postcode(s) [8]
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- Herston
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Recruitment postcode(s) [9]
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- Hornsby
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Recruitment postcode(s) [10]
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- Kogarah
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Recruitment postcode(s) [11]
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- Kurralta Park
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Recruitment postcode(s) [12]
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- Lismore
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Recruitment postcode(s) [13]
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- Liverpool
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Recruitment postcode(s) [14]
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- Malvern
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Recruitment postcode(s) [15]
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- Parkville
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Recruitment postcode(s) [16]
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- Perth
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Recruitment postcode(s) [17]
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- South Brisbane
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Recruitment postcode(s) [18]
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- Southport
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Recruitment postcode(s) [19]
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- Subiaco
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Recruitment outside Australia
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United States of America
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Alabama
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Colorado
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Connecticut
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Florida
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Georgia
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Kansas
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Louisiana
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Maryland
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Gent
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United Kingdom
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State/province [91]
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Wirral
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Funding & Sponsors
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Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Summary
Brief summary
This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC).
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Trial website
https://clinicaltrials.gov/study/NCT00887198
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Trial related presentations / publications
Lorente D, Llacer C, Lozano R, de Velasco G, Romero-Laorden N, Rodrigo M, Sanchez-Iglesias A, di Capua C, Castro E, Ferrer C, Sanchez-Hernandez A, Olmos D. Prognostic Score and Benefit from Abiraterone in First-line Metastatic, Castration-resistant Prostate Cancer. Eur Urol. 2021 Nov;80(5):641-649. doi: 10.1016/j.eururo.2021.07.014. Epub 2021 Aug 6. Miller K, Carles J, Gschwend JE, Van Poppel H, Diels J, Brookman-May SD. The Phase 3 COU-AA-302 Study of Abiraterone Acetate Plus Prednisone in Men with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer: Stratified Analysis Based on Pain, Prostate-specific Antigen, and Gleason Score. Eur Urol. 2018 Jul;74(1):17-23. doi: 10.1016/j.eururo.2017.08.035. Epub 2017 Sep 20. de Bono JS, Smith MR, Saad F, Rathkopf DE, Mulders PFA, Small EJ, Shore ND, Fizazi K, De Porre P, Kheoh T, Li J, Todd MB, Ryan CJ, Flaig TW. Subsequent Chemotherapy and Treatment Patterns After Abiraterone Acetate in Patients with Metastatic Castration-resistant Prostate Cancer: Post Hoc Analysis of COU-AA-302. Eur Urol. 2017 Apr;71(4):656-664. doi: 10.1016/j.eururo.2016.06.033. Epub 2016 Jul 9. Fizazi K, Flaig TW, Stockle M, Scher HI, de Bono JS, Rathkopf DE, Ryan CJ, Kheoh T, Li J, Todd MB, Griffin TW, Molina A, Ohlmann CH. Does Gleason score at initial diagnosis predict efficacy of abiraterone acetate therapy in patients with metastatic castration-resistant prostate cancer? An analysis of abiraterone acetate phase III trials. Ann Oncol. 2016 Apr;27(4):699-705. doi: 10.1093/annonc/mdv545. Epub 2015 Nov 25. Saad F, Shore N, Van Poppel H, Rathkopf DE, Smith MR, de Bono JS, Logothetis CJ, de Souza P, Fizazi K, Mulders PF, Mainwaring P, Hainsworth JD, Beer TM, North S, Fradet Y, Griffin TA, De Porre P, Londhe A, Kheoh T, Small EJ, Scher HI, Molina A, Ryan CJ. Impact of bone-targeted therapies in chemotherapy-naive metastatic castration-resistant prostate cancer patients treated with abiraterone acetate: post hoc analysis of study COU-AA-302. Eur Urol. 2015 Oct;68(4):570-7. doi: 10.1016/j.eururo.2015.04.032. Epub 2015 May 16. Xu XS, Ryan CJ, Stuyckens K, Smith MR, Saad F, Griffin TW, Park YC, Yu MK, Vermeulen A, Poggesi I, Nandy P. Correlation between Prostate-Specific Antigen Kinetics and Overall Survival in Abiraterone Acetate-Treated Castration-Resistant Prostate Cancer Patients. Clin Cancer Res. 2015 Jul 15;21(14):3170-7. doi: 10.1158/1078-0432.CCR-14-1549. Epub 2015 Mar 31. Morris MJ, Molina A, Small EJ, de Bono JS, Logothetis CJ, Fizazi K, de Souza P, Kantoff PW, Higano CS, Li J, Kheoh T, Larson SM, Matheny SL, Naini V, Burzykowski T, Griffin TW, Scher HI, Ryan CJ. Radiographic progression-free survival as a response biomarker in metastatic castration-resistant prostate cancer: COU-AA-302 results. J Clin Oncol. 2015 Apr 20;33(12):1356-63. doi: 10.1200/JCO.2014.55.3875. Epub 2015 Jan 26. Ryan CJ, Smith MR, Fizazi K, Saad F, Mulders PF, Sternberg CN, Miller K, Logothetis CJ, Shore ND, Small EJ, Carles J, Flaig TW, Taplin ME, Higano CS, de Souza P, de Bono JS, Griffin TW, De Porre P, Yu MK, Park YC, Li J, Kheoh T, Naini V, Molina A, Rathkopf DE; COU-AA-302 Investigators. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2015 Feb;16(2):152-60. doi: 10.1016/S1470-2045(14)71205-7. Epub 2015 Jan 16. Attard G, de Bono JS, Logothetis CJ, Fizazi K, Mukherjee SD, Joshua AM, Schrijvers D, van den Eertwegh AJ, Li W, Molina A, Griffin TW, Kheoh T, Ricci DS, Zelinsky K, Rathkopf DE, Scher HI, Ryan CJ. Improvements in Radiographic Progression-Free Survival Stratified by ERG Gene Status in Metastatic Castration-Resistant Prostate Cancer Patients Treated with Abiraterone Acetate. Clin Cancer Res. 2015 Apr 1;21(7):1621-7. doi: 10.1158/1078-0432.CCR-14-1961. Epub 2015 Jan 15. Aggarwal R, Harris A, Formaker C, Small EJ, Molina A, Griffin TW, Ryan CJ. Response to subsequent docetaxel in a patient cohort with metastatic castration-resistant prostate cancer after abiraterone acetate treatment. Clin Genitourin Cancer. 2014 Oct;12(5):e167-72. doi: 10.1016/j.clgc.2014.03.010. Epub 2014 Mar 28. Rathkopf DE, Smith MR, de Bono JS, Logothetis CJ, Shore ND, de Souza P, Fizazi K, Mulders PF, Mainwaring P, Hainsworth JD, Beer TM, North S, Fradet Y, Van Poppel H, Carles J, Flaig TW, Efstathiou E, Yu EY, Higano CS, Taplin ME, Griffin TW, Todd MB, Yu MK, Park YC, Kheoh T, Small EJ, Scher HI, Molina A, Ryan CJ, Saad F. Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302). Eur Urol. 2014 Nov;66(5):815-25. doi: 10.1016/j.eururo.2014.02.056. Epub 2014 Mar 6. Basch E, Autio K, Ryan CJ, Mulders P, Shore N, Kheoh T, Fizazi K, Logothetis CJ, Rathkopf D, Smith MR, Mainwaring PN, Hao Y, Griffin T, Li S, Meyers ML, Molina A, Cleeland C. Abiraterone acetate plus prednisone versus prednisone alone in chemotherapy-naive men with metastatic castration-resistant prostate cancer: patient-reported outcome results of a randomised phase 3 trial. Lancet Oncol. 2013 Nov;14(12):1193-9. doi: 10.1016/S1470-2045(13)70424-8. Epub 2013 Sep 25. Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE; COU-AA-302 Investigators. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013 Jan 10;368(2):138-48. doi: 10.1056/NEJMoa1209096. Epub 2012 Dec 10. Erratum In: N Engl J Med. 2013 Feb 7;368(6):584.
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Janssen Research & Development, LLC Clinical Trial
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Janssen Research & Development, LLC
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Results publications and other study-related documents
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Results are available at
https://clinicaltrials.gov/study/NCT00887198
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